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Phase II trial of gemcitabine plus irinotecan in patients with esophageal cancer: a Southwest Oncology Group (SWOG) trial.

Publication ,  Journal Article
Williamson, SK; McCoy, SA; Gandara, DR; Dakhil, SR; Yost, KJ; Paradelo, JC; Atkins, JN; Blanke, CD; Abbruzzese, JL; Southwest Oncology Group (SWOG),
Published in: Am J Clin Oncol
April 2006

OBJECTIVES: Metastatic esophageal carcinoma is an incurable disease with median survival duration of 6 to 8 months. Based on preclinical data suggesting a dose-dependent synergy between gemcitabine and irinotecan we have conducted a phase II trial in patients with advanced or metastatic esophageal carcinoma. METHODS: Patient eligibility included a diagnosis of squamous cell or adenocarcinoma of the esophagus/gastroesophageal (GE) junction, metastatic or recurrent disease, no CNS metastasis, no prior chemotherapy, prior adjuvant/neoadjuvant chemotherapy was allowed, no prior gemcitabine or irinotecan, performance status of 0 to 2 and adequate organ function. Patients received gemcitabine 1000 mg/m2 and irinotecan 100 mg/m2 given day 1 and day 8, every 3 weeks. The primary end point was the 6-month survival rate. The secondary end point was to assess qualitative and quantitative toxicities. RESULTS: Fifty-seven eligible patients were accrued. There were 4 treatment-related deaths. The primary grade 3 to 4 toxic events were diarrhea, dehydration, neutropenia, thrombocytopenia, anemia, and anorexia; and 4 episodes of grade 3 to 5 febrile neutropenia, 1 fatal. The study was designed to detect a difference between the null hypothesis of 30% 6-month survival and the alternative hypothesis of 50% 6-month survival. The Kaplan-Meier estimate of 6-month survival is 56% (95% CI: 43-69%), with a median of 6.3 months. The median time to progression was 3.7 months. The 6-month progression-free survival estimate is 25% (95% CI: 13-36%). CONCLUSIONS: The length of survival suggests that this combination has benefit similar to platinum containing regimens, however, the toxicity is substantial and is unlikely to prove superior to platinum containing regimens.

Duke Scholars

Published In

Am J Clin Oncol

DOI

EISSN

1537-453X

Publication Date

April 2006

Volume

29

Issue

2

Start / End Page

116 / 122

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Irinotecan
  • Infusions, Intravenous
  • Humans
  • Gemcitabine
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Williamson, S. K., McCoy, S. A., Gandara, D. R., Dakhil, S. R., Yost, K. J., Paradelo, J. C., … Southwest Oncology Group (SWOG), . (2006). Phase II trial of gemcitabine plus irinotecan in patients with esophageal cancer: a Southwest Oncology Group (SWOG) trial. Am J Clin Oncol, 29(2), 116–122. https://doi.org/10.1097/01.coc.0000199883.10685.2b
Williamson, Stephen K., Sheryl A. McCoy, David R. Gandara, Shaker R. Dakhil, Kathleen J. Yost, Jorge C. Paradelo, James N. Atkins, Charles D. Blanke, James L. Abbruzzese, and James L. Southwest Oncology Group (SWOG). “Phase II trial of gemcitabine plus irinotecan in patients with esophageal cancer: a Southwest Oncology Group (SWOG) trial.Am J Clin Oncol 29, no. 2 (April 2006): 116–22. https://doi.org/10.1097/01.coc.0000199883.10685.2b.
Williamson SK, McCoy SA, Gandara DR, Dakhil SR, Yost KJ, Paradelo JC, et al. Phase II trial of gemcitabine plus irinotecan in patients with esophageal cancer: a Southwest Oncology Group (SWOG) trial. Am J Clin Oncol. 2006 Apr;29(2):116–22.
Williamson, Stephen K., et al. “Phase II trial of gemcitabine plus irinotecan in patients with esophageal cancer: a Southwest Oncology Group (SWOG) trial.Am J Clin Oncol, vol. 29, no. 2, Apr. 2006, pp. 116–22. Pubmed, doi:10.1097/01.coc.0000199883.10685.2b.
Williamson SK, McCoy SA, Gandara DR, Dakhil SR, Yost KJ, Paradelo JC, Atkins JN, Blanke CD, Abbruzzese JL, Southwest Oncology Group (SWOG). Phase II trial of gemcitabine plus irinotecan in patients with esophageal cancer: a Southwest Oncology Group (SWOG) trial. Am J Clin Oncol. 2006 Apr;29(2):116–122.

Published In

Am J Clin Oncol

DOI

EISSN

1537-453X

Publication Date

April 2006

Volume

29

Issue

2

Start / End Page

116 / 122

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Irinotecan
  • Infusions, Intravenous
  • Humans
  • Gemcitabine
  • Female